Clinical Trial: Feasibility of mindBEAGLE in Disorders of Consciousness or Locked-In Syndrome

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Feasibility Study of the mindBEAGLE Device in Patients With Disorders of Consciousness or Locked-In Syndrome

Brief Summary:

The primary aims of this study are:

  1. To determine the feasibility of deploying mindBEAGLE, a portable, bedside EEG-based system, in the Intensive Care Unit in patients with disorders of consciousness (DOC) or locked-in syndrome (LIS);
  2. To determine if mindBEAGLE neurophysiologic markers of cognitive function correlate with bedside behavioral assessments of consciousness;
  3. To determine if mindBEAGLE neurophysiologic markers of cognitive function correlate with functional MRI (fMRI) and electroencephalography (EEG) biomarkers of consciousness;
  4. To determine if mindBEAGLE can serve as an assistive communication device for people with LIS.

Detailed Summary:
Sponsor: Massachusetts General Hospital

Current Primary Outcome: Behavioral Diagnosis of Level of Consciousness (LoC) [ Time Frame: on the day of intervention ]

LoC will be defined using the Coma Recovery Scale-Revised behavioral evaluation (score range 0-23)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Neuroimaging Biomarkers of LoC [ Time Frame: within 1 week of the intervention ]
    functional MRI biomarkers of conscious awareness (+ or - activation during auditory stimulus)
  • EEG Biomarkers of LoC [ Time Frame: within 1 week of the intervention ]
    resting EEG biomarkers of conscious awareness (power in delta, theta, and alpha frequency bands)


Original Secondary Outcome: Same as current

Information By: Massachusetts General Hospital

Dates:
Date Received: March 30, 2016
Date Started: March 2016
Date Completion: March 2019
Last Updated: May 11, 2016
Last Verified: May 2016